Pilot Study to Evaluate A Novel Gastric Space Occupying Device

A Single-Center 60-day Observational, Non-randomized Study to Evaluate Safety and Preliminary Efficacy of a Novel Gastric Space Occupying Device as an Aid for Weight Loss

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01444274

Enrollment

Registered

2011-09-30

Start date

2011-07-31

Completion date

2011-09-30

Last updated

2019-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

This will be an observational, prospective, non-randomized, pilot study to gain initial device experience on a novel space-occupying device in persons who are overweight or obese. No formal hypothesis testing will be conducted.

Interventions

DEVICEObalon Gastric Balloon(s)

One or two balloons administered per patient

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

1. Age between 21-64 years 2. BMI 27-40 Kg/m2 3. No history of weight reduction of more than 5% of total body weight in the past 6 months

Exclusion criteria

1. Have unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity; 2. Be taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and unwillingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure; 3. Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months; 4. Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin; 5. History or symptoms of thyroid disease which is not controlled by medication; 6. Have severe renal, hepatic, pulmonary disease or cancer; 7. Past history of gastrointestinal surgery (excluding uncomplicated appendectomy); 8. Have a history of adhesive peritonitis; 9. History or symptoms of esophageal and/or gastric varices; 10. Have history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula); 11. History or symptoms of inflammatory bowel disease, such as Chron's disease; 12. History of/ signs and /or symptoms of duodenal or gastric ulcer; 13. Have gastroparesis; 14. Pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential); 15. Currently using pharmaceutical agents for weight loss;

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026